Type 2 diabetes treatment market share worldwide,type 1 diabetes driving uk mod,project m installer - PDF Books


Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. Diabetes mellitus is a group of metabolic diseases characterized by chronic hyperglycemia - high blood glucose levels - that results from defects in insulin secretion, insulin action, or a combination of these. Clipping is a handy way to collect and organize the most important slides from a presentation.
FDA Advisory Panel votes 8-2 in favor of an insulin dosing label update for Dexcom's G5 CGM! After months of anticipation, Victoza, Novo Nordisk’s once-daily GLP-1 analog (similar to Byetta), was approved on January 25, 2010, for sale in the US. However, while approval spells safe to use, the product will carry a “black-box” warning, FDA’s method for cautioning against potentially serious side effects – in Victoza’s case, medullary thyroid carcinoma, or MTC (a very rare cancer of specific cells within the thyroid gland called C-cells). Our mission is to help individuals better understand their diabetes and to make our readers happier & healthier. Our mission is to help individuals better understand their diabetes and to make our readers happier and healthier.
Novo Nordisk's (NVO) new type-2 diabetes drug Victoza is rapidly gaining market share in the all-important U.S. Older diabetic drugs, such as insulin analogs and oral sulfonylureas, have a propensity to cause weight gain and increase the risk of hypoglycemia. Clinical data supporting the ability of Byetta to address the unmet need of glucose control with potential weight loss quickly became a winning narrative for the drug, with analysts predicting peak sales of more than $1 billion annually by 2010. Prescription momentum swung away from Byetta, however, after reports began to surface of a link between Byetta use and kidney function problems. The number of patients treated worldwide with Byetta dropped from 470,000 in 2007 to 440,000 in 2009, according to data obtained by Wolters Kluwer.


Even regulatory blessing for Byetta as the only GLP-1 agonist approved for first-line use in type 2 diabetes, did little to impress endocrinologists and primary care physicians: For week-ending June 4, total new prescriptions (refills and new patient starts) for Byetta and Victoza were 37,398 and 8,551, respectively, down four percent and up 42 percent from week-ending April 30, according to proprietary IMS Script (RX) Data (leaked on a Cafepharma message board). That Victoza continues to gain ground at Byetta's expense is all the more impressive when one considers that the drug was launched with onerous luggage too:a "black box" warning of thyroid C-cell tumors in both rats and mice. Goldman Sachs (GS) and other Wall Street firms predict global sales of Victoza will reach $1 billion in just two years. Pending an approvable letter, analysts are modeling worldwide sales for Bydureon of more than $3 billion by 2016 - 2017.The revenue potential of the Byetta franchise, however, could be significantly lowered by a one-two punch of near-term competion from Victoza and longer-term competion from incretin-like therapuetics in the pipeline, said Wolters Kluwer analyst Ben Weintraub. Although the timeline for Roche's (RHHBY) promising GLP-1 taspoglutide has been delayed for up to 18 months due to hypersensitivity problems in trial subjects, GlaxoSmithKline's (GSK) Syncria (albiglutide, also a once-weekly injection) is expected to report results from several late-stage trials by year-end 2010. David Phillips has more than 25 years' experience on Wall Street, first as a financial consultant and then as an equity analyst for several investment banking firms.
Powered and implemented by Interactive Data Managed Solutions News provided by The Associated Press. FDA okayed the drug for both use as an add-on therapy to metformin, sulfonylureas (such as glimepiride), and thiazolidinediones (Actos and Avandia), as well as a single agent for those who aren’t able to tolerate sulfonylureas or metformin. While signals for MTC still have never been seen in humans, the drug will not be recommended in those with a personal or family history of MTC or multiple endocrine neoplasia syndrome type 2, a rare genetic disorder that predisposes individuals to MTC. The GLP-1 agonist became the fourth most-prescribed branded product for type 2-diabetes -- after Actos, Avandia and Lantus -- within 18 months of its June 2005 launch. From April 2005 to October 2007, the FDA received 30 reports of acute pancreatitis in patients taking Byetta. With the unknown of long-term use of Victoza and thyroid malignancies, the FDA mandated that Novo establish a 15-year cancer registry to monitor the rate of medullary thyroid cancer in the U.S.
Novo has to move quickly to build its market position, as the FDA is expected to issue an opinion on a more convenient dose of Byetta, a once-weekly injection called Bydureon, by October 22.


The latest weekly statistics show that the number of new Victoza prescriptions increased by another 13.6 percent to 7,232, while the total number of new prescriptions increased by 15 percent to 12,163. The first of the “next generation” GLP-1 analogs (next-in-line exenatide once-weekly or EQW is up for approval later this month), Victoza has a promising profile in collectively speaking – in addition to lowering A1c about 1% on average, it prompts weight loss of 5-7 pounds (unlike the weight gain seen with sulfonylureas, thiazolidinediones, and insulin), isn’t associated with hypoglycemia, requires a very thin needle gauge, is dosed only once-a-day, and can be taken at any time of day.
Due to the warning, various post-approval studies will be required of Novo Nordisk, including a 15-year cancer registry, a long term risk-evaluation study, and further preclinical studies - this is in addition to a cardiovascular safety study.
The Danish drug maker's early commercial success with its subcutaneous "GLP-1" diabetes treatment is troubling news for Amylin Pharmaceuticals (AMLN) and marketing partner Eli Lilly's (LLY) in-kind, Byetta franchise. In patients with type-2 diabetes, the incretin effect is thought to be impaired or absent totally. While studies show less nausea than for Byetta, still about 43% of patients taking the drug did experience some nausea - that said, you can see clever ways around this, such as Carol King's tip of taking it right before sleep to avoid the feeling. And that may be a good thing, as it means Victoza could have lots of supportive safety data in the long run.
Overall, we found the FDA’s response very positive – in its approval, the agency stressed the importance of getting drugs on the market that reduced the long-term complications associated with diabetes, and we definitely see Victoza as a step in the right direction (leaders of the FDA said as much in a recent article in the prestigious New England Journal of Medicine). The drug is now available in 90% of US pharmacies nationwide – for one person’s experience with Victoza, see Test Drive in this issue of diaTribe, and if your current therapy isn't working for you, think about asking your healthcare provider about GLP-1.



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